Health Problem: An atrial septal defect (ASD) is a congenital cardiac anomaly that permits blood flow between the left and right sides of the heart. These defects can range from a few millimeters to 3 centimeters in diameter. ASDs occur in 0.1% of all live births and account for 10% of all congenital heart disease and up to 40% of congenital heart disease presenting in adulthood.

Technology Description: The Gore Cardioform Septal Occluder is a permanent intracardiac device that closes ASDs and stops or significantly diminishes left-to-right cardiac shunting. The Gore Cardioform Septal Occluder is inserted via catheter percutaneously through the right femoral vein and advanced to the heart. When fully deployed, the device assumes a double-disc configuration on either side of the atrial septum, thereby blocking the ASD.

Controversy: The most commonly used percutaneous device to treat an ASD is the Amplatzer Septal Occluder. The Amplatzer device is rigid and associated with late cardiac wall erosion, which can be fatal. The Gore Cardioform Septal Occluder is soft, pliable, and conforms to the shape of the cardiac wall, so may have a lower risk of cardiac erosion. However, no studies are currently available directly comparing the safety and efficacy of these 2 devices.

Key Questions:

  • Is the Gore Cardioform Septal Occluder effective at closing atrial septal defects (ASDs)?
  • How does the Gore Cardioform Septal Occluder compare with other septal occluders for the treatment of ASD?
  • Is the Gore Cardioform Septal Occluder safe for treatment of ASD?
  • Have definitive patient selection criteria been identified for Gore Cardioform Septal Occluder?

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